We are seeking a Senior Technical Product Owner with deep expertise in Manufacturing Execution Systems (MES) and Computerized System Validation (CSV/CSA) for a leadership role driving digital transformation across pharmaceutical manufacturing operations. The ideal candidate brings a proven track record of end-to-end MES implementations, global regulatory compliance, and cross-functional team leadership across multiple manufacturing sites.
This role sits at the intersection of Product Offering and Technology — championing compliant, scalable, and innovative MES solutions that support shop-floor excellence, data integrity, and inspection readiness.
Key Responsibilities:
Product Ownership & Strategy
- Own the MES product roadmap, prioritizing features aligned to GxP compliance, business value, and operational efficiency.
- Define product vision for composable or modular MES architectures, supporting digital factory initiatives.
- Partner with solution consulting, sales, and customer success teams to drive product adoption and ARR growth.
- Lead Voice of Customer (VoC) exercises to incorporate manufacturing site requirements into the product backlog.
MES Implementation & Technical Leadership
- Lead end-to-end Product Requirements for MES— from requirements to Product Release
- Define Solution architecture, integration parameters (ERP/SAP, LIMS, QMS, DMS, LES, CDS), data flows, and interface specifications.
- Govern computerized system validation (CSV) and computer software assurance (CSA) activities per GAMP 5, 21 CFR Part 11, Annex 11, and EU GMP requirements.
- Manage batch record, electronic logbook, scheduling, sampling, and shopfloor execution modules within MES.
- Support PLC/SCADA/DAS integration and resolve technical challenges in manufacturing environments.
Regulatory Compliance & Data Integrity
- Ensure MES deployments are audit-ready for USFDA, MHRA, TGA, WHO, and other global regulatory bodies.
- Champion data integrity principles (ALCOA+) across all computerized systems.
- Lead system audit assessments, compliance gap analysis, and remediation planning.
- Author and review GxP documentation including URS, FS, DS, IQ/OQ/PQ protocols, and SOP/PQR documentation.
Project & Stakeholder Management
- Identify and map all relevant stakeholders across engineering, business, sales, customers, and regulatory/compliance teams
- Build and maintain strong working relationships with cross-functional partners including R&D, QA, implementation, and commercial teams
- Collaborate with regulatory, quality, and compliance teams to ensure product requirements align with applicable standards (e.g., FDA 21 CFR Part 11, EU MDR/GMP)
- Engage with auditors, notified bodies, or customer validation teams during product qualification activities
- Serve as the primary point of contact between technical teams and business stakeholders
- Present product strategy, business cases, and investment decisions to senior leadership and executive sponsors
Innovation
- Continuously scan the market, competitive landscape, and emerging technologies to identify innovation opportunities relevant to the product domain
- Champion a product vision that goes beyond incremental improvements — anticipating future customer needs rather than just responding to current ones
- Maintain and prioritize an innovation backlog distinct from the operational feature backlog
- Establish co-innovation partnerships with key customers to jointly define and validate new product capabilities.
Evaluate and advocate for adoption of emerging technologies (AI/ML, cloud-native architectures, IoT, digital twins, etc.) where they create measurable product value
Required Qualification & Experience
Education
- M.Tech / BTech/ B.Pharm / B.Sc in Pharmaceutical Sciences, Chemical Engineering, or related technical discipline.
Experience
- 15–20+ years of progressive experience in Life Sciences manufacturing IT, quality systems, or related domains.
- Demonstrated experience at leading pharma companies in Manufacturing or Quality
- 10+ years experience in MES Project execution and delivery at leading Pharma companies
Technical Expertise
- **Deep expertise in MES platforms such as Werum PAS-X, Rockwell PharmaSuite, Honeywell TWM, or equivalent.: **MES Platforms
- **ERP, LIMS, QMS, DMS, LES, LMS, CDS, SAP HANA, SCADA/DAS/PLC, eCTD, RPA, ZOHO Vault, Argus, LSRIMS.: **Systems
- **GxP, GAMP 5, 21 CFR Part 11, Annex 11, EU GMP, USFDA, MHRA, TGA, WHO.: **Regulatory Frameworks
- **PERT, Critical Path Analysis, IFAS/EFAS/SFAS, Lean Six Sigma (Black Belt preferred).: **Project Management
- **Power BI, Tableau, Visio, MS Project.: **Analytics
Certifications (Preferred)
- Lean Six Sigma Black Belt
- Product Management certification
- GxP Audit Certification
- GAMP 5 Practitioner or equivalent CSV/CSA certification
Behavioral Competencies
- Strategic Thinking – Ability to translate manufacturing challenges into scalable digital solutions.
- Leadership & Influence – Proven ability to lead large, cross-functional, globally dispersed teams.
- Customer Centricity – Deep understanding of pharma customer implementation journeys and pain points.
- Analytical Rigor – Data-driven decision-making with strong risk assessment capabilities.
- Communication – Strong executive-level communication and stakeholder management skills.
- Continuous Improvement – Demonstrated culture of Kaizen, Lean thinking, and operational excellence.